Study of Stored Tumor Samples in Young Patients With Brain Tumors - Full Text View

Sponsor:	St. Jude Children's Research Hospital
Information provided by (Responsible Party):	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00897286

Purpose

This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Condition
Brain and Central Nervous System Tumors

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas Adn Medulloblastoma/PNET of the Pediatric CNS

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Fresh frozen, fixed and cultured tumor cells collected prospectively from a clinically well characterized patient cohort.

Estimated Enrollment:	250
Study Start Date:	November 2004
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Tumor/Tissue Sample Tumor material collected prospectively from a clinically well characterized patient cohort

Detailed Description:

The overall objective of this non-therapeutic protocol is to identify molecular abnormalities within prospectively treated pediatric CNS Atypical Teratoid Rhabdoid Tumors (ATRT) and Choroid Plexus Carcinomas (CPC), Ependymoma and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and protein analysis tools to the study of fresh frozen, fixed and cultured tumor cells. The establishment of cell cultures from each tumor sample will also allow for in vitro analysis of tumor cell growth, signaling and therapeutic response.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants will have ATRT, CPC, medulloblastoma/PNET or ependymoma of the CNS as documented by the local neuropathologist. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort.

Criteria

Inclusion Criteria

ATRT, CPC, medulloblastoma/PNET or ependymoma of the CNS as documented by the local neuropathologist. Tumor may be primary, progressive or relapsed disease.
Age not more than 21 years at the time of initial diagnosis.
Enrollment in the current version of the institution's banking protocol

Exclusion Criteria

Diagnosis other than ATRT, CPC, medulloblastoma/PNET or ependymoma of the central nervous system.
Age greater than 21 years at the time of diagnosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897286

Contacts

Contact: Amar Gajjar, MD

1-866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Amar Gajjar, MD 866-278-5833 info@stjude.org

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:	Amar Gajjar, MD	St. Jude Children's Research Hospital
Principal Investigator:	Richard J. Gilbertson, MD, PhD	St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00897286 History of Changes
Other Study ID Numbers:	NBTP01
Study First Received:	May 9, 2009
Last Updated:	January 3, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:

childhood atypical teratoid/rhabdoid tumor
childhood choroid plexus tumor
childhood medulloblastoma
recurrent childhood medulloblastoma
childhood infratentorial ependymoma

childhood supratentorial ependymoma
recurrent childhood ependymoma
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood supratentorial primitive neuroectodermal tumor

Additional relevant MeSH terms:

Ependymoma
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Rhabdoid Tumor
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Neoplasms by Site
Nervous System Diseases
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on May 23, 2012